Personalized Translational Platform for Biomarker Discovery in Brain Tumors
1 other identifier
observational
37
1 country
2
Brief Summary
The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2010
CompletedFirst Posted
Study publicly available on registry
November 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 29, 2017
August 1, 2017
6.3 years
November 10, 2010
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
7 months
Progression free Survival
MRI and clinical criteria
7 months
Study Arms (1)
Patients with high grade gliomas
All subjects will have radiographically suspected or surgically proven de novo high grade gliomas. There are no control patients.
Interventions
Each patient will have 0-3 or more FLT-PET brain scans.
Eligibility Criteria
Patients presenting to BWH/DFCI emergency department (ED), inpatient, or neurology/ neurosurgery/ radiation oncology clinics with newly diagnosed brain masses (suspected high grade gliomas) will be consented and enrolled in this study after adequate explanation of the risks and benefits of the study.
You may qualify if:
- Newly diagnosed or suspected high grade glioma ≥ 1cm in diameter on postoperative anatomic imaging (contrast MRI), prior to initiation of chemoXRT
- Anticipated survival ≥6 months
- Able to give informed consent
- Capable of undergoing MRI and PET scans without the need for sedation or general anesthesia
- Male or Female
You may not qualify if:
- Prior radiation therapy and chemotherapy to the brain
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (\<1 month)
- Expected survival \<6 months
- Pregnant or nursing
- Renal failure
- Lives far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcelo F. Di Carli, MD, FACClead
- Society of Nuclear Medicine and Molecular Imagingcollaborator
- General Electriccollaborator
Study Sites (2)
University of California at San Diego
San Diego, California, 92093, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Kijewski, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief of Nuclear Medicine/PET
Study Record Dates
First Submitted
November 10, 2010
First Posted
November 15, 2010
Study Start
December 1, 2009
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 29, 2017
Record last verified: 2017-08